Regulation Agency for Medical and Pharmaceutical Activities of Georgia
Georgia RAMA · Georgia · europe
Georgia's Regulation Agency for Medical and Pharmaceutical Activities (Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Georgia
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://rama.moh.gov.ge
Relevant Regulation Codes
- Georgian Law on Medicinal Products and Pharmaceutical Activities
- Georgian national medical device regulatory framework (progressively aligning with EU MDR 2017/745 as part of EU accession process)
- Georgian framework for traditional and folk medicine where applicable
Prescriber Requirements
- Ministry of Health–licensed physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Agency registration as applicable; Georgian-language labelling required by national law (with English-language supplementary information where relevant). Standard cold-chain conditions.
Import/Export Rules
Ministry of Health and National Food Agency clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Universal Healthcare Programme (UHCP) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; Georgia sits at the regulatory interface of the post-Soviet space and the EU accession trajectory. The contemporary statutory pathway for hirudotherapy has not been independently mapped by ASH.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.